NEWS HIGHLIGHTS
Published Studies Related to Sublimaze (Fentanyl)
Efficacy and long-term tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain. [2009.10.08]
Abstract Background and objectives: Breakthrough cancer pain (BTcP) represents an important clinical challenge in the care of patients with cancer. This trial evaluated the efficacy and long-term tolerability of a sublingual formulation of the fast-acting opioid fentanyl, for the treatment of BTcP in opioid-tolerant patients with cancer...
Analgesia during abdominal aortic aneurysm endovascular repair: remifentanil vs. fentanyl-midazolam--a randomized controlled trial. [2009.09]
BACKGROUND AND OBJECTIVE: Endovascular repair offers a less surgically invasive procedure for abdominal aortic aneurysms but nevertheless, still requires analgesic sedative cover to ensure an acceptable level of patient comfort and cardiorespiratory stability. The peculiarity of this kind of operation is that painful stimuli are concentrated in specific moments separated by intervals devoid of pain, so the insurgence of pain can be predicted and prevented with a bolus of analgesic, making a continuous infusion not essential, but potentially useful in achieving a better analgesic stability. The primary objective of the study was pain control measured by Visual Analogue Scale; secondary endpoints were cardiorespiratory stability and an acceptable level of sedation... CONCLUSION: Both techniques were shown to be safe and most importantly effective in offering cardiovascular stability and analgesia for American Society of Anaesthesiologists III-IV patients undergoing endovascular abdominal aortic aneurysm repair. However, remifentanil continuous infusion proved to offer significantly more stable pain control compared with the currently used combination fentanyl-midazolam.
Morphine-based cardiac anesthesia provides superior early recovery compared with fentanyl in elective cardiac surgery patients. [2009.08]
BACKGROUND: Experimental and clinical data suggest that morphine possesses unique cardioprotective and antiinflammatory properties. In this clinical investigation, we sought to determine whether the choice of intraoperative opioid (morphine or fentanyl) influences early recovery after cardiac surgery... CONCLUSIONS: In patients undergoing elective cardiac surgery with cardiopulmonary bypass, postoperative quality-of-life measures and pain control during recovery were enhanced when morphine (40 mg) was administered intraoperatively as part of a balanced anesthetic technique compared with fentanyl.
The effects of dexmedetomidine and fentanyl on emergence characteristics after adenoidectomy in children. [2009.07]
This randomised controlled study evaluated the effects of fentanyl and dexmedetomidine on emergence characteristics of children having adenoidectomy and anaesthetised with sevoflurane. Ninety children, two to seven years of age and ASA physical status I, were studied.Further studies of dexmedetomidine safety and its interaction with other anaesthetic agents are required before recommending its routine use during general anaesthesia in children.
Subarachnoid morphine, bupivacaine and fentanyl as part of combined spinal-epidural analgesia for low anterior resection. A prospective, randomised, double-blind clinical trial. [2009.07]
This study was designed to compare the efficacy of subarachnoid morphine alone or in combination with bupivacaine and fentanyl for combined spinal-epidural analgesia in colorectal surgery... The addition of bupivacaine and fentanyl to subarachnoid morphine did not confer any advantage on postoperative visual analogue scale scores and tramadol use, but lowered the need for additional intraoperative intravenous fentanyl and epidural bupivacaine and prolonged the time to first analgesia request.
Clinical Trials Related to Sublimaze (Fentanyl)
This Open-Label Study Will Evaluate in Daily Clinical Practice the Safety and Efficacy of a Fentanyl Iontophoretic Transdermal System (Fentanyl ITS) for Management of Moderate to Severe Acute Pain in Postoperative Patients Who Have Undergone Elective Spine or Orthopaedic Surgery. [Recruiting]
This open-label study will evaluate in daily clinical practice the safety and efficacy of a
fentanyl Iontophoretic Transdermal System (fentanyl ITS) for management of moderate to severe
acute pain in postoperative patients who have undergone elective spine or orthopaedic
surgery.
Epidural Fentanyl-Bupivacaine Versus Clonidine-Bupivacaine for Breakthrough Pain in Advanced Labor [Not yet recruiting]
Epidural analgesia is widely regarding as the most effective analgesic strategy for labor
pain. Modern practice is to utilize dilute local anesthetics as a continuous infusion along
with an opioid, e. g., our common "recipe" of 12 ml/hr of 0. 0625% bupivacaine with 2
micrograms/ml fentanyl, after the initial dose to maintain patient comfort until delivery.
This dose of the infusion often provides adequate comfort without interfering with the
mobility of the patient and her ability to effectively push during delivery. However, this
low dose epidural infusion strategy often results in recurrence of pain after an initial
pain free period.
This breakthrough pain is treated by administering small boluses of analgesics via the
epidural catheter. The pain occurring in labor is initially of visceral origin and is
mediated by pain fibers originating from the low thoracic and upper lumbar segments of the
spinal cord. As labor progresses to the late first phase (also known as transitional stage),
pain sensations originating from the distension of the pelvic floor, vagina and perineum
adds a somatic component to labor pain. This type of breakthrough pain is often difficult to
treat.
Although requests from patients to alleviate late stage breakthrough pain are common, no one
knows the most effective strategy for pain management in this stage of labor. This study is
designed to compare the efficacy of two treatments for controlling late first stage
breakthrough pain during labor with an epidural infusion in place: clonidine-bupivacaine
versus fentanyl-bupivacaine.
Women who have labor epidural analgesia in place will be enrolled to be randomized if and
when they present with breakthrough pain in the late first stage or second stage of labor
(≥ 8 cm dilated). They will receive 8 ml of a solution containing 10 mg bupivacaine and 75
micrograms of either fentanyl (an opioid or "narcotic") or clonidine (an "alpha-2 agonist
known to be effective as an epidural analgesic).
Pain relief, labor progress and outcome will be assessed to compare fentanyl versus
clonidine.
It is the hypothesis of this study that clonidine added to bupivacaine is a better analgesic
than fentanyl added to bupivacaine for breakthrough pain in advanced labor.
Long Term Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioid Therapy [Recruiting]
Cancer patients taking regular medication for their pain often still have episodes of severe
pain that 'break through' despite their background pain treatment. Fentanyl is a strong,
short-acting pain killer often used to treat this 'breakthrough' pain. Nasalfent contains
fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal
spray. This study will examine the long-term safety of Nasalfent in the treatment of
breakthrough cancer pain.
Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy [Recruiting]
The primary purpose of this study is:
1. To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and
post-operative analgesia.
2. To determine an analgesic dose response relationship for dexmedetomidine.
3. Compare recovery characteristics of dexmedetomidine to fentanyl.
Safety of Fentanyl TAIFUN Treatment [Recruiting]
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